LAMICTAL
- Product NDC
- 21695-224
- 11-digit product format
- 216950224
- Labeler code
- 21695
- Product ID
- 21695-224_17a20462-d9d2-43ac-bcad-603e8cc76e3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lamotrigine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA020241
- Marketing category
- NDA
- Marketing start
- 1995-01-17
- Marketing end
- 0000-00-00
- Substance
- LAMOTRIGINE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Anti-epileptic Agent [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 14a9502b-3d70-0496-a7e1-b16edaa005b8 | Product name | 5 | 20250423 |
| 16d731ed-ff3e-e9a1-3e3e-1ef6b6be40a0 | Product name | 7 | 20250401 |
| e29d8e8b-4bc8-ebaf-f18e-e35287b19d6a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-224-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4731-48b1-e053-8cdaa90a720a | These highlights do not include all the information needed to use LAMICTAL safely and effectively. See full prescribing information for LAMICTAL. LAMICTAL (lamotrigine) Tablets LAMICTAL (lamotrigine) Chewable Dispersible Tablets LAMICTAL ODT (lamotrigine) Orally Disintegrating Tablets Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-224-15 | LAMICTAL | 15 in 1 BOTTLE | TABLET | 15 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-224-15 | EA - Each | 21695-224 | 6c013570-1fc1-4eda-9626-d8bcd26507c2 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LAMOTRIGINE | ACTIVE INGREDIENT | U3H27498KS | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LAMOTRIGINE | ACTIVE MOIETY | U3H27498KS | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | LAMICTAL (LAMOTRIGINE) TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 105018 | LaMICtal 100 MG Oral Tablet | PSN | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 206201 | LaMICtal 150 MG Oral Tablet | PSN | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 198427 | lamoTRIgine 100 MG Oral Tablet | PSN | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 198428 | lamoTRIgine 150 MG Oral Tablet | PSN | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 105018 | lamotrigine 100 MG Oral Tablet [Lamictal] | SBD | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 206201 | lamotrigine 150 MG Oral Tablet [Lamictal] | SBD | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 198427 | lamotrigine 100 MG Oral Tablet | SCD | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 198428 | lamotrigine 150 MG Oral Tablet | SCD | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 105018 | Lamictal 100 MG Oral Tablet | SY | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
| 206201 | Lamictal 150 MG Oral Tablet | SY | 17a20462-d9d2-43ac-bcad-603e8cc76e3b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-224-15 | 21695022415 | 15 in 1 BOTTLE | Historical |